Pharma & Biotech Pricing, Policy & Regulation
Pharmaceutical
In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards. 25 November 2024
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Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Pharmaceutical
A new indication for olverembatinib, developed by Suzhou-based Ascentage Pharma will be added to China’s National Reimbursement Drug List (NRDL) from next year. 28 November 2024
Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of classic galactosemia, under development by Applied Therapeutics. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeOne Medicines, formerly BeiGene. 27 November 2024
Biotechnology
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
Pharmaceutical
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
Pharmaceutical
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Pharmaceutical
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
Pharmaceutical
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Pharmaceutical
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Biotechnology
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
Pharmaceutical
Canada’s medicines regulator has issued a safety warning related to Boehringer Ingelheim’s idiopathic pulmonary fibrosis (IPF) therapy Ofev. 12 January 2018
Pharmaceutical
The risk of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with prescription cough and cold medicines containing codeine or hydrocodone outweighs their benefits in patients younger than 18. 12 January 2018
Biotechnology
Today, Ocrevus (ocrelizumab) was granted a licence by the European Commission to treat people with two forms of multiple sclerosis (MS) including the first and only licence for primary progressive MS (PPMS), the most debilitating form of the disease, in which disability increases from the outset. 12 January 2018
Pharmaceutical
Codeine is no better for pain than other over-the-counter (OTC) medicines, Australia’s Chief Medical Officer has said. 12 January 2018
Pharmaceutical
The latest report from the US-China Economic and Security Review Commission (USCC) notes a number of key factors suggesting improving opportunities for the global pharmaceutical industry in China. 11 January 2018
Pharmaceutical
Japanese drug major Astellas Pharma has submitted an application in Japan for the additional indication of the selective SGLT2 inhibitor Suglat (ipragliflozin L-proline) for the treatment of type 1 diabetes mellitus in Japan. 11 January 2018
Pharmaceutical
Pharma giants Pfizer and Roche are two of seven sponsors announced for a pioneering project to generate, align and share disease-level data across an entire condition for health technology assessments (HTA). 10 January 2018
Pharmaceutical
Following the Brexit vote, the UK is already seeing problems in filling senior positions at life sciences companies, says DHR International, the global executive search firm. 10 January 2018
Biotechnology
One of the hottest biotech stocks in 2017 was Vertex Pharmaceuticals, a US biotech that specializes in cystic fibrosis (CF), with its value nearly doubling and the company reporting positive data from Phase I and II trials of triple combination regimens. 10 January 2018
Pharmaceutical
According to US Food and Drug Administration regulations, the regulatory agency may refuse to file a new drug application (NDA) or biologics license application (BLA) when either is deemed incomplete, writes Dr Nicola Davies in her monthly blog for The Pharma Letter. 10 January 2018
Generics
In a posting on the US Food and Drug Administration’s website, FDA Commissioner Scott Gottlieb reflects on the achievements of the agency in 2017, a record year for new product approvals. 10 January 2018
Pharmaceutical
The growing volume of data collected in clinical trials is contributing to longer development times and posing technical and integration challenges to clinical data management staff, according to a recently completed analysis by the Tufts Center for the Study of Drug Development. 10 January 2018
Biotechnology
Eisai's multiple receptor tyrosine kinase inhibitor Lenvima (lenvatinib) in combination with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) for the potential treatment of patients with advanced and/or metastatic renal cell carcinoma (RCC) has been granted 'Breakthrough' status in the USA. 9 January 2018
Pharmaceutical
Taking a cue from the state governments of Haryana and Punjab, which have negotiated the price of hepatitis C drugs and started free treatment of hepatitis C patients in their jurisdiction, India's health ministry is looking to negotiate the price of the drug for inclusion in a national program. The ministry is in talks with Indian companies which manufacture sofosbuvir on behalf of American biotech giant Gilead Sciences (Nasdaq: GILD), reports The Pharma Letter’s India correspondent. 9 January 2018
Pharmaceutical
The Netherlands’ Medicines Evaluation Board (MEB) believes that the discussion about expensive medicines should not just focus on costs. 8 January 2018
Pharmaceutical
News flow last week was dominated by hints as to what is coming up at the prestigious JP Morgan annual healthcare conference which starts today. Elsewhere, a US court is questioning the Valeant Pharmaceuticals and Pershing Square settlement with Allergan; and Novartis has bagged another Breakthrough therapy designation for its Kisqali. Two licensing deals also attracted attention, that of AstraZeneca with ANI Pharmaceutical, and Takeda Pharmaceutical buying rights to early-stage neurodegenerative disease compounds from Denali Therapeutics. 7 January 2018
Biotechnology
The US Food and Drug Administration (FDA) has issued a warning to American CryoStem Corporation for marketing an adipose derived stem cell product without FDA approval and for significant deviations from current good manufacturing practice (GMP), including some that risk patient safety. 5 January 2018
Biotechnology
Announcements from US gene therapy company Spark Therapeutics on the pricing of Luxturna (voretigene neparvovec-rzyl) have set tongues wagging in pharma for a number of reasons. 4 January 2018
Pharmaceutical
In an important step for the development of the medicinal cannabis sector and to secure long-term supplies for Australian patients, the federal government will permit the export of medicinal cannabis products, it was announced today. 4 January 2018
Generics
Following a record year for generic drug approvals in 2017, the US Food and Drug Administration yesterday issued the draft guidance for industry “Good ANDA Submission Practices,” which highlights common, recurring deficiencies in Abbreviated New Drug Applications (ANDAs) that may lead to a delay in the approval of an ANDA. 4 January 2018
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